Device Problems
Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
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Event Description
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It was reported that there was an issue with the arcticsun gel pads, and they were replaced.Additional information was requested, but there is no recollection on the event form the complainant.
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Manufacturer Narrative
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The reported event could not be confirmed.No sample was returned for evaluation.A potential root cause for this failure is ""belt temperatures too low after nip roller and heated section.The lot number is unknown therefore the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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Event Description
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It was reported that there was an issue with the arcticsun gel pads, and they were replaced.Additional information was requested, but there was no recollection on the event form the complainant.
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Search Alerts/Recalls
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